Use of a topical composition containing epidermal growth factor (egf) for diabetic foot amputation prevention

Abstract

The present invention is related to the use of topical formulations that contain epidermal growth factor encapsulated in or associated to deformable or conventional liposomes to be applied on the surface of and around chronic ischemic skin lesions. The formulations of the present invention, in contrast with the previous art, are useful because they provide a high bioavailability of EGF in the tissue deep below the lesions and for preventing diabetic foot amputation.

1 . Use of an effective amount of epidermal growth factor encapsulated in or associated to deformable or conventional liposomes for manufacturing a topical pharmaceutical formulation for the treatment of grade IV and V chronic ischemic skin lesions in diabetic patients. 
   
   
       2 . The use of  claim 1 , wherein a high bioavailability of epidermal growth factor is achieved in the tissue deep below the lesions. 
   
   
       3 . The use of  claim 1 , for preventing diabetic foot amputation, wherein the formulation is applied onto the surface and around chronic ischemic skin lesions. 
   
   
       4 . A topical pharmaceutical formulation that contains an effective amount of epidermal growth factor encapsulated in or associated to deformable or conventional liposomes, wherein the liposome is comprised of one or more pharmaceutically acceptable lipids, provides a high bioavailability of epidermal growth factor in the tissue deep below chronic ischemic skin lesions, and is useful for preventing diabetic foot amputation. 
   
   
       5 . A topical pharmaceutical formulation according to  claim 4 , wherein the effective amount of epidermal growth factor is in the range from 0.025 to 0.075 mg/gram of substance. 
   
   
       6 . A topical pharmaceutical formulation according to  claim 4 , wherein the effective amount of epidermal growth factor is 0.075 mg/gram of substance. 
   
   
       7 . A topical pharmaceutical formulation according to  claim 4 , wherein the liposome is comprised of one or more pharmaceutically acceptable lipids selected from the group consisting of a neutral lipid, a negatively charged lipid, a positively charged lipid, a lipid conjugated to polyethylene glycol or a lipid conjugated to a carbohydrate. 
   
   
       8 . A topical pharmaceutical formulation according to  claim 4 , wherein the liposome is comprised of one or more pharmaceutically acceptable lipids and one or more non-ionic, zwitterionic, anionic, or cationic surfactant agents.